Z-0630-2014 Class II Terminated
FDA device recall Z-0630-2014 was initiated by Stryker Instruments Div. Of Stryker Corporation on Dec 6, 2013 and is designated Class II. Reason for recall: The Color Cuff¿ Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect end-connector. A customer reported having received a luer connector instead of a quick connect… The recall status is terminated (terminated Feb 27, 2014). Affected quantity: 5 boxes (50 units).
Recall details
- Product Type
- Devices
- Report Date
- Jan 15, 2014
- Initiation Date
- Dec 6, 2013
- Termination Date
- Feb 27, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 boxes (50 units)
Product description
Stryker Color Cuff, REF 5921-034-135 Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm) Single Bladder, Single Port, QuickConnect Rx only, STERILE
Reason for recall
The Color Cuff¿ Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect end-connector. A customer reported having received a luer connector instead of a quick connect fitting. An incorrect connector may lead to an inoperable system due to incompatibility with the Smart Pump.
Distribution pattern
US Distribution: including states of: MI, OH, and TX.
Code information
Lot 50731155 Color code Purple
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0630-2014
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026